Treatment with oral tecovirimat (TPOXXTM) can be considered in consultation with a physician from the Monkeypox Advisory and Guidance in the following patients with confirmed monkeypox infection:
- Individuals (adults and children irrespective of age or smallpox vaccine status) with severe disease defined as either:
- Requiring hospitalization or hospital-level care for monkeypox (e.g., due to severe, extensive and widespread lesions*) OR
- Requiring hospitalization or hospital-level care for complications directly related to monkeypox (e.g., encephalitis, sepsis, pneumonia), OR
- Significantly interfering with normal physiological body function (e.g., oral food intake, hydration, pain that is difficult to control or severe pain with bowel movements or urination)
*Note: Many patients will present with genital, anal and/or oral lesions, as well as conjunctivitis. The location of lesions itself is not an indication for treatment. Treatment decisions should be based on the severity of the presentation.
- Individuals who may be at high-risk# of developing severe disease due to severe immunocompromise such as:
- human immunodeficiency virus with a CD4 count < 200 cells/mm3, or a diagnosis of acquired immune deficiency syndrome for adults or a diagnosis of HIV for children
- current treatment for a hematological malignancy such as leukemia or lymphoma
- bone marrow/HSCT transplantation in the past 2 years
- generalized malignancy (e.g., solid tumor or metastatic cancer)
- solid organ transplantation
- therapy with severely immunosuppressing agents (e.g., alkylating agents, antimetabolites, radiation, tumor necrosis factor inhibitors, high-dose corticosteroids, treatment for graft-versus-host disease or receiving immunosuppressive therapy for an autoimmune disease with immunodeficiency as a clinical component)
- Neonates and infants < 1-year-old
- Children aged 1-17 years with immunocompromising conditions (e.g., HIV, cancer, currently taking immunosuppressive therapy)
- Pregnant persons
#Clinical judgement must be used when offering tecovirimat to non-severely ill patients who have been vaccinated with the smallpox vaccine (Vaccinia; Imvamune). Such patients are less likely to develop severe disease; however, the impact of smallpox vaccination in high-risk individuals infected with the recent strain of monkeypox has not been well characterized. In addition, vaccine timing (recent vs. decades ago) and immune status (during illness and at the time of vaccination) may impact vaccine response and must be strongly considered.
The recommended tecovirimat dosing is 600mg PO BID for adults weighing 40-124kg and 600mg PO TID for adults weighing 125kg or more.
The recommended duration of initial treatment is 7 days, with reassessment for the possibility of continued therapy for a total of 14 days. Treatment may be stopped after 7 days in those who are not severely ill, who are improving clinically and/or at the clinician’s judgement. Treatment should be extended to 14 days in pregnant patients, those who remain hospitalized, those who are not experiencing improvement/experiencing progression, severely immunocompromised individuals exhibiting new lesions while on treatment, and/or at the clinician’s judgement.
Pediatric dosing is weight-based: 13 to < 25kg: 200mg PO BID; 25 to < 40kg: 400mg PO BID; 40kg and over: refer to adult dosing. Tecovirimat capsules may be opened, mixed with food, or dissolved in liquid and given via feeding tubes. An IV formulation may be applied for through the Special Access Programme for those who are unable to take PO medications or for neonates between 3-13kg.